Postoperative Pain in Adult Patients.

Pain, Postoperative Clinical Trial

Official title:

Survey of Postoperative Pain Control in Adults After Different Types of Surgeries.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731039
• Other study ID #: WLNZ/DS/3/2018
• Status: Completed
• Start date: September 21, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: July 2020
• Source: Andrzej Frycz Modrzewski Krakow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Each surgical intervention associated with even a minor tissue injury is a source of pain which needs to be effectively controlled. Although the Polish national guidelines for post-operative pain management have been published, many patients experience moderate and severe pain in the postoperative period. The aim of this study is (1) to assess pain severity among adult patients after different types of surgeries; (2) to identify demographic and clinical factors associated with postoperative pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• adult

• elective surgery

• the American Society of Anesthesiologists score 1-3

Exclusion Criteria:

• diagnosed mental illness, alcohol abuse disorders, intellectual disability

• traumatic events within the last 6 months (e.g. death, breakdown of a relationship, job loss)

• problems with verbal communication

Related Conditions & MeSH terms

• Pain, Postoperative
• Surgical Procedures, Operative

Intervention

Other:
• Observational study
Pain assessment, Anxiety assessment, Depression assessment

Locations

Country	Name	City	State
Poland	Andrzej Frycz-Modrzewski Krakow University	Krakow	Lesser Poland

Sponsors (1)

Lead Sponsor	Collaborator
Andrzej Frycz Modrzewski Krakow University

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Borys M, Zyzak K, Hanych A, Domagala M, Galkin P, Galaszkiewicz K, Klaput A, Wróblewski K, Miekina J, Onichimowski D, Czuczwar M. Survey of postoperative pain control in different types of hospitals: a multicenter observational study. BMC Anesthesiol. 2018 Jul 18;18(1):83. doi: 10.1186/s12871-018-0551-3. — View Citation

Misiolek H, Cettler M, Woron J, Wordliczek J, Dobrogowski J, Mayzner-Zawadzka E. The 2014 guidelines for post-operative pain management. Anaesthesiol Intensive Ther. 2014 Sep-Oct;46(4):221-44. doi: 10.5603/AIT.2014.0041. — View Citation

Tomaszek L, Debska G. Knowledge, compliance with good clinical practices and barriers to effective control of postoperative pain among nurses from hospitals with and without a "Hospital without Pain" certificate. J Clin Nurs. 2018 Apr;27(7-8):1641-1652. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity scores at rest	Pain intensity is assessed using the Numeric Rating Scale (NRS), where 0 meant no pain and 10 maximum pain. Numeric scores of 1-3, 4-6, and 7-10 corresponded to mild, moderate and severe pain.	first 24 hours after surgery
Primary	Pain intensity scores on movement	Pain intensity is assessed using the Numeric Rating Scale (NRS), where 0 meant no pain and 10 maximum pain. Numeric scores of 1-3, 4-6, and 7-10 corresponded to mild, moderate and severe pain.	first 24 hours after surgery
Secondary	Anxiety scores	Anxiety is evaluated using the Hospital Anxiety and Depression Scale - HADS. It consists of 7 items grouped in sub-scales: anxiety (HADS-A) and depression (HADS-D). The answers describe the patient's well-being over the last week and are coded on a scale of 0-3 points.; HADS-A: the total score amounts to 0-21 points (0-7 points = norm, 8-10 = borderline, =11 points = clinical levels of symptoms).	day prior to surgery
Secondary	Depression scores	Depression is evaluated using the Hospital Anxiety and Depression Scale - HADS. It consists of 7 items grouped in sub-scales: anxiety (HADS-A) and depression (HADS-D). The answers describe the patient's well-being over the last week and are coded on a scale of 0-3 points.; HADS-D: the total score amounts to 0-21 points (0-7 points = norm, 8-10 = borderline, =11 points = clinical levels of symptoms).	day prior to surgery